Biocryst ORLADEYO Reduced HAE Attack Rate by 80% from Baseline

  BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that hereditary angioedema (HAE) patients who were randomized to receive 150 mg of oral, once-daily ORLADEYO® (berotralstat) at the start of the APeX-2 trial had an 80 percent average reduction in their mean attack rate per month during weeks 25-96 of the trial, compared to baseline. Median attack rates also decreased from 2.7 attacks/month at baseline to 0.0 attacks per month in 16 of 17 months through the same period.

ORLADEYO was generally well-tolerated during the treatment period with fewer drug-related adverse events reported in part 3 (weeks 49-96) as compared to part 1 (weeks 0-24) and part 2 (weeks 25-48). Eighty-one percent of the patients who entered part 3 completed the trial.

“The long-term data we now see from two years of therapy in the clinical program reinforces the substantial, sustained reduction in HAE attacks patients experienced with ORLADEYO. These results are consistent with the experience many patients are having in the real world since we launched ORLADEYO, which is a key driver for the strong patient demand we are seeing as patients switch from injectable prophylactic agents and injectable acute-only therapies to oral, once-daily ORLADEYO for control of their HAE attacks,” said Dr. William Sheridan, chief medical officer of BioCryst.

The data are scheduled to be presented in an oral presentation on Monday, July 12, 2021 at 2:15pm CET at the EAACI Hybrid Congress 2021.

https://finance.yahoo.com/news/biocryst-reports-96-week-data-140000408.html